Background The aim of this study was to perform the first femtosecond laser cuts with a new prototype femtosecond laser, in vivo and to evaluate its safety, stability and efficacy.

Methods A LASIK cut was performed with a prototype 200 kHz femtosecond laser in both eyes of nine patients and one eye of two patients (20 individual eyes in total). A complete ophthalmic examination was performed preoperatively and postoperatively at 1, 3, 6 and 12 months after the procedure.

Results In the pilot series of 20 eyes, flap creation was possible in each case. The mean preoperative manifest refractive spherical equivalent was À−4.22 D (SD±61.22 D). The postoperative spherical equivalent refraction was À−0.1 D (SD±60.26 D) at 1 month, À−0.22 D (SD±60.24 D) at 3 months and À−0.15 D (SD±60.16 D) 12 months after surgery.

Conclusions Femto-LASIK with this new laser system showed high levels of safety, stability and efficacy without any enhancement.

Clinical trials registration http://www.dimdi.de. DE/CA126/AP4/3332/27/09. Bfam registration 09/03/2009, DE/CA126.